Glenmark Pharma gets USFDA gesture for generic drug

Overview

• Post By : Kumar Jeetendra


• Source: PTI


• Date: 19 Oct,2020

New Delhi, Oct 19 (PTI) Glenmark Pharmaceuticals on Monday said it has received approval by the US health regulator to market Sirolimus pills, an immunosuppressant, in the American market.
The company”s US-based subsidiary has received final approval from the US Food and Drug Administration (USFDA) for the item which is a generic version of PF Prism CV”s Rapamune tablets, Glenmark Pharmaceuticals said in a statement.

Sirolimus tablets are prescribed for preventing rejection of kidney transplant either alone or with other medications.

According to IQVIA sales statistics for the 12-month period ending August 2020, the Rapamune achieved annual sales of around USD 119.7 million.

Glenmark stated its current portfolio consists of 165 products authorised for distribution in the US market and has 45 abbreviated new drug applications (ANDAs) pending with the USFDA for acceptance.

Besides these internal filings, the company continues to identify and research outside development partnerships to supplement and accelerate the growth of its current pipeline and portfolio, it included. PTI MSS ANS ANS